Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings for the Diagnosis of Either Acute Kidney Injury or Chronic Kidney Disease in Routine Practices (NEPHROCT)

NCT05728216 | Recruiting

• 1 other identifier: NEPHROCT
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney biopsy play a key role for the investigation of either acute kidney injury or chronic kidney disease. Despite possible complications due to the invasive nature of the biopsy, such procedure is still essential in a number of clinical situations to improve the diagnosis specificity of kidney disease, better inform about its prognosis and guide the management of a future treatment. Pursuing the idea to improve both performance and rapidity associated with the histopathological analysis of kidney biopsy, with a possible recourse to artificial intelligence-based renal pathology, the present study intends to assess the impact of direct histopathological examination of kidney biopsy with dynamic full-field optical coherence tomography in routine practices for the diagnosis of either acute kidney injury or chronic kidney disease.

Conditions

Acute Kidney Injury; Chronic Kidney Diseases; Tomography, Optical Coherence

Keywords

Tomography, Optical Coherence; Chronic Kidney Diseases; Acute Kidney Injury; Kidney Biopsy

Outcome Measures

Primary Outcomes (1)

• Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography

  Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize common glomerular (abnormal / double contour of the glomerular basement membrane, focal segmental glomerulosclerosis, collapse of the glomerular tuft, proliferation of glomerular epithelial cells, endocapillary proliferation, mesangial expansion, necrosis and proliferation with mild increase in extracapillary cells...), vascular (hyaline change, fibrinoid change / necrosis, thrombosis, inflammation or necrosis of vascular walls, arteriosclerosis) and tubulointerstitial (acute tubular necrosis, cytoplasmic vacuolization, lipid inclusions in proximal / distal tubular cells, atrophy of tubules, edema, inflammation or interstitial fibrosis, cortical necrosis) lesions seen in kidney biopsy

  Outcome measure is assessed 15 days following kidney biopsy

Secondary Outcomes (1)

• Histopathological analysis of healthy kidney biopsy with dynamic full-field optical coherence tomography

  Outcome measure is assessed 15 days following kidney biopsy

Study Arms (1)

NEPHROCT cohort

Patients \> 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department

Other: Dynamic full-field optical coherence tomography analysis of kidney biopsy

Interventions

Dynamic full-field optical coherence tomography analysis of kidney biopsy OTHER

Dynamic full-field optical coherence tomography analysis of kidney biopsy in the nephrology department before conventional histopathological analysis

NEPHROCT cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients \> 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department

You may qualify if:

• patients \> 18 years of age with suspected acute kidney injury requiring biopsy in the nephrology department
• patients \> 18 years of age with suspected chronic kidney disease requiring biopsy in the nephrology department

You may not qualify if:

• inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy

Sponsors & Collaborators

• Centre Hospitalier William Morey - Chalon sur Saône: lead
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (1)

Centre Hospitalier William Morey - Chalon sur Saône

Chalon-sur-Saône, Saône-et-Loire, 71100, France

RECRUITING

Related Publications (2)

• Hull KL, Adenwalla SF, Topham P, Graham-Brown MP. Indications and considerations for kidney biopsy: an overview of clinical considerations for the non-specialist. Clin Med (Lond). 2022 Jan;22(1):34-40. doi: 10.7861/clinmed.2021-0472. Epub 2021 Dec 17.

  PMID: 34921054 BACKGROUND

• Jain M, Robinson BD, Salamoon B, Thouvenin O, Boccara C, Mukherjee S. Rapid evaluation of fresh ex vivo kidney tissue with full-field optical coherence tomography. J Pathol Inform. 2015 Sep 28;6:53. doi: 10.4103/2153-3539.166014. eCollection 2015.

  PMID: 26605118 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Maldiney

  Centre Hospitalier William Morey - Chalon sur Saône

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Maldiney

CONTACT

+33 3 85 91 01 11; thomas.maldiney@ch-chalon71.fr

Quentin Bernard

CONTACT

quentin.bernard@ch-chalon71.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 15, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (1)